TORONTO ¿ GlycoDesign Inc. is steering toward the clinic a new indication for its lead anticancer compound, which is showing promise as a means of reducing side effects associated with other chemotherapies.
In preclinical studies, the compound ¿ GD0039 ¿ demonstrated significant chemoprotective properties, and the company intends to gauge its effectiveness in humans, following approval from the FDA to start a Phase I/II study for this indication.
The protocol calls for evaluating the effects of oral GD0039 administered to advanced breast cancer patients receiving combination chemotherapy with FAC, a standard chemotherapy cocktail that includes the cytotoxic agents 5-FU, doxorubicin and cyclophosphamide.
Clinical trials are set to begin this spring at the University of Chicago Medical Center. The multicenter trial is expected to enroll 28 patients, and has been designed to study the response to GD0039 over multiple cycles of combination chemotherapy with FAC. The study is expected to expand to additional U.S. centers later in the year.
Julie Dzerowicz, communications and business development associate at GlycoDesign, told BioWorld Inter national that the initiation of this trial represents a significant milestone for the company, because it will allow the properties of GD0039 to be tested in a completely new indication other than its anticancer role.
GD0039 is in Canadian Phase II clinical trials as an anticancer agent in renal cell carcinoma and colorectal cancer.
The rationale for developing GD0039 as a chemoprotective agent is based on animal studies, in which protection against the lethality of various cytotoxic chemotherapeutic agents and radiation has been demonstrated.
Jeremy Carver, president and CEO of GlycoDesign, said existing therapies are not meeting the needs of advanced breast cancer patients. GD0039 may represent a new option, given its potential dual action as an anticancer agent and reducing some of the side effects associated with chemotherapy. ¿Ultimately, we are setting out to improve chemotherapy by making it more effective and more humane,¿ Carver said, adding that GD0039 is a novel carbohydrate processing inhibitor (CPI).
CPIs are small-molecule, orally active inhibitors of enzymes responsible for the synthesis of the key carbohydrate structures involved in disease. GlycoDesign¿s scientists were among the first in the world to identify the specific carbohydrate structures, located on the surface of tumor cells, that facilitate the invasion and spread of cancer. Cell-surface carbohydrates are also involved in regulating cell growth and multiplication, immune responses, and the ability of viruses and bacteria to adhere to healthy cells. n